CURENDO (Cord-blood Uterine Regeneration Endometrium): Platelet-rich Plasma Therapy Derived From Umbilical Cord Blood for the Treatment of Endometrial Pathologies (Asherman Syndrome / Endometrial Atrophy / Thin Endometrium)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Increase in endometrial thickness following treatment with hUC-PRP, calculated as the difference between the endometrial thickness after treatment and the patient's initial endometrial thickness (mm).
研究概览
简要总结
In recent years, platelet-rich plasma (PRP) has emerged as a promising alternative for treating endometrial pathologies that affect the endometrial lining. Several studies have tested this therapeutic approach in human patients, but the results are inconclusive. Moreover, in recent years, different investigations have suggested that PRP derived from umbilical cord blood (hUC-PRP) contains a higher concentration of growth factors and other pro-regenerative molecules than PRP obtained from adult peripheral blood. In our previous pilot study conducted in 15 patients with endometrial atrophy/Asherman syndrome/thin endometrium, preliminary results indicate that hysteroscopic injection of hUC-PRP increases endometrial thickness and improves the endometrial pattern. For this reason, the present study aims to corroborate our previous findings by increasing the number of patients to 35, in prior HRT cycles in these women, to gain a deeper understanding of the effectiveness of this new therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 48 years at the time of recruitment
- •body mass index (BMI): ≥ 18 kg/m2 and ≤ 35 kg/m2
- •endometrial thickness < 5 mm despite estrogen administration according to each clinic's routine practice for 10 or more days and/or evidence of Asherman syndrome.
排除标准
- •Active genital infection at the time of recruitment
- •chronic endometritis
- •known endometrial pathology
- •psychiatric disorder that could hinder study follow-up
- •positive results on viral safety testing (HBsAg, HBcAb, HCV, HIV-1, HIV-2, syphilis)
- •presence of any syndrome or condition that, in the opinion of the principal investigator, could pose a risk to the study or to the patient
- •any clinically significant abnormality detected during the recruitment process
- •simultaneous participation in another clinical study that could affect the objectives of the present study, or prior participation in this same study.
结局指标
主要结局
Increase in endometrial thickness following treatment with hUC-PRP, calculated as the difference between the endometrial thickness after treatment and the patient's initial endometrial thickness (mm).
时间窗: 8 weeks
If more than one endometrial thickness measurement is recorded, the average of the measurements will be calculated.
次要结局
未报告次要终点